Therapy Areas: Diabetes
City of Hope Researchers Help Expand Treatment Options for Patients with Advanced Colorectal Cancer
16 December 2021 - - California, US-based cancer research and treatment organization City of Hope has posted study results of a Phase 2 clinical trial showing monotherapy with sotorasib resulted in anti-tumor activity and a favorable benefit-risk profile among heavily pretreated patients with advanced colorectal cancer, the organization said.

The research was published this week in Lancet Oncology.

Colorectal cancer is the third most common cancer diagnosed in the United States and the second leading cause of cancer death, according to the Centers for Disease Control and Prevention.

The research study focused on a subset of colorectal cancer patients who carry a mutated gene called KRAS G12C, which is estimated to inflict about 4% of people with colorectal cancer tumors, said Marwan Fakih, M.D., lead study author and co-director of the Gastrointestinal Cancer Program at city of Hope. 

KRAS mutations have been linked to worse overall survival in colorectal cancer, partly because they are resistant to targeted therapies that inhibit the EGFR protein, a pathway that enables cancer cell growth.

While the response rate in the study did not meet expectations, the ongoing, single-arm Phase 2 CodeBreaK 100 trial showed an objective response rate of 9.7% among the 62 patients enrolled, with six patients achieving a partial response. 

Disease control (complete response, partial response or stable disease) was achieved in 82% of patients.

Median progression-free survival and overall survival were four months and nearly 11 months, respectively.

Patients had received a median of three prior treatment regimens of systemic anti-cancer therapy, with 73% of patients receiving three or more previous lines of treatment prior to participating in this study.

Most treatment-related side effects were minor (grade 1-2) and included diarrhea and nausea.

Currently, overall response rate for patients with recurrent metastatic colorectal cancer who take approved options, such as trifluridine and regorafenib, ranges from 1-4%, Fakih said.

Their estimated median progression-free survival and overall survival range from two to three months and six to nine months, respectively.

The CodeBreaK 100 data for this patient population demonstrates better response rate and longer survival than current approved medicines.

The study, "Sotorasib for previously treated colorectal cancers with KRAS p.G12C mutation (CodeBreaK100): an interim analysis of a single-arm, Phase 2 trial," was supported by industry sponsor Amgen Inc.

City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases.

Founded in 1913, city of Hope is in bone marrow transplantation and immunotherapy such as CAR T cell therapy.

City of Hope's translational research and personalized treatment protocols advance care throughout the world.

Human synthetic insulin, monoclonal antibodies and numerous breakthrough cancer drugs are based on technology developed at the institution.

A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, city of Hope is ranked among the nation's "Best Hospitals" in cancer by US News and World Report.

Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona. 

Translational Genomics Research Institute became a part of city of Hope in 2016. AccessHope, a subsidiary launched in 2019, serves employers and their health care partners by providing access to NCI-designated cancer center expertise.
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